Extended Post-operative Oral TXA in Primary THA

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOregon Health and Science University

About this trial

The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone? Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates. Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis. They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.

Eligibility criteria

Qualifiers

Age ≥18 years

Undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis

Ability to provide written informed consent

Willingness to comply with study protocol

Disqualifiers

History of venous thromboembolism (DVT or PE)

Active malignancy

Allergy or contraindication to tranexamic acid (TXA)

Post-operative anticoagulation therapy other than aspirin

Trial design

Treatments tested in this trial

  • Extended oral tranexamic acid regimen
  • Placebo

Treatment groups

170 Participants
are divided into 2 treatment groups

Locations

This trial has no locations